EP0132285A2 - Dispositif pour essais médicaux et chimiques - Google Patents

Dispositif pour essais médicaux et chimiques Download PDF

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Publication number
EP0132285A2
EP0132285A2 EP84303969A EP84303969A EP0132285A2 EP 0132285 A2 EP0132285 A2 EP 0132285A2 EP 84303969 A EP84303969 A EP 84303969A EP 84303969 A EP84303969 A EP 84303969A EP 0132285 A2 EP0132285 A2 EP 0132285A2
Authority
EP
European Patent Office
Prior art keywords
reagent
test kit
test
elements
compartment
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP84303969A
Other languages
German (de)
English (en)
Other versions
EP0132285A3 (fr
Inventor
Robert Barclay Goudie
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
University of Glasgow
Original Assignee
University of Glasgow
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by University of Glasgow filed Critical University of Glasgow
Publication of EP0132285A2 publication Critical patent/EP0132285A2/fr
Publication of EP0132285A3 publication Critical patent/EP0132285A3/fr
Withdrawn legal-status Critical Current

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/528—Atypical element structures, e.g. gloves, rods, tampons, toilet paper

Definitions

  • the subject of this invention is a kit for use in performing medical tests or chemical tests requiring the consecutive application of different reagents.
  • kits require, for convenience of handling, bottles of a minimum volume and individual labeling of the bottles. This labeling operation is labour-intensive and can be a source of error. It also adds considerably to the cost of the kits. Also many of the reagents used in tests are expensive and have a restricted storage life which may even be considerably reduced as a result of the contamination referred to above. Because the bottles have a minimum volume it frequently happens that quantities of expensive reagents have to be discarded because they have exceeded their storage life.
  • An object of the present invention is to provide a kit for use in performing medical or chemical tests in which the aforesaid disadvantages of previously proposed testing kits are obviated or mitigated.
  • a test kit for performing'medical or chemical tests comprising a plurality of continuous elongated reagent-containing elements, each element containing a particular reagent, and means capable of defining a predetermined quantity of each reagent at spaced intervals along the length of the elements whereby each predetermined quantity of reagent can be selectively removed from its associated element in order to permit application thereof in a particular test.
  • the number of reagent-containing elements contained in the kit will be dictated by the number and volume of reagents required for a particular test or a specific part of a test or a set of tests or specific parts of the tests of a set.
  • the plurality of elements is secured to a common anchorage constituted by, for example, a pin, a ring, a card or a piece of sheet material which may be synthetic plastics material,to which the elements are attached, or a series of reels or spools having a common mounting or axis, each element being wound around an individual reel or spool.
  • the elements may be attached to the common anchorage in the order in which the reagents are to be used.
  • the common anchorage is constituted by a card or a piece of sheet material it may be formed with grooves or recesses in which the elements lie, thereby protecting the elements and reducing any risk that the elements may become inconveniently entangled.
  • a tab or label containing at least the information as to which element is first in the order of reagents to be applied or identifying each element and the order in which its contents are to be used in the test, may be attached to the anchorage, the tab or label also detailing the test for which that particular kit is intended to be used.
  • the tab or label may also list the reagents contained in the elements.
  • the common anchorage is a card or a piece of sheet material
  • any desirable information about the reagents in the kit and/or the test for which the kit is usable may be applied to the card or piece of sheet material.
  • the elements may be colour-coded by means of solid colouring or by coloured bands or dots, and the tab or label may then carry a colour marking opposite each reagent listed.
  • the elements may be transparent and the reagents may themselves be coloured, where this is not objectionable.
  • the elements may be closed at the ends and may be closeable at intermediate points by being knotted or otherwise sealed, e.g. by pinching.
  • they may be pinched and heat sealed, or sealed by ultrasonic or high frequency welding techniques.
  • Suitable materials for the elements are polyvinylchloride and polyethylene.
  • the elements should be flexible and sufficiently pliable to enable the reagent to be readily expelled.
  • Tubular elements with an internal diameter of 2.0 mm are particularly suitable for delivering approximately 0.1 ml volumes of reagent, the tubular elements being pinched or sealed at intervals of approximately 32 mm.
  • each element may be attached to the pin or the ring by simply knotting it around the pin or the ring.
  • the set of elements required for one particular test may be connected directly to an identifying tab by knotting at least one of the elements through a hole in the tab, the other elements being then knotted together at that end as well as being individually knotted to act as a seal.
  • the tab then functions also as the anchorage.
  • the common anchorage is a card or a piece of sheet material e.g. a sheet of plastics material one end of each element may be attached to the common anchorage, e.g. by gluing or heat sealing or by ultrasonic or high frequency welding or by adhesive tape, leaving the other end of the element free.
  • kits at least one substance which does not require to be held in specific small aliquots or under special conditions of sterility.
  • a substance might be a disinfectant. It may then be convenient to include in the kit a larger bottle of that substance held in a conventional fashion, for example held by frictional grip in a container linked to the common anchorage.
  • lA,lB and lC denote flexible tubular elements containing the different reagents specific to a particular test, each element being knotted at 2 at one end and being attached at the other end to a tab 3 marked with information about the test for which this kit may be used and containing an indication of the contents of the individual elements, the indication being by means of the colours of the elements and the tab indicating the order in which the elements of each colour are to be used.
  • the elements are attached toille tab by one of their number being passed through a hole in the tab and then being knotted to the rest of the elements which are first knotted to close them off, the elements being then plaited for convenience.
  • lA, 1B, 1C, 1D etc. indicate different tubular elements again containing different reagents but in a larger number, the elements also being knotted as at 2 at both ends and being passed around and knotted to a ring 4, in the order in which they will be used.
  • a tab 5 is attached to the ring, the tab carrying the name of the test and indicia showing the contents of the various tubular elements in the order in which they occur starting from the tab.
  • a sheet 7 of synthetic plastics material has connected thereto at one end 8 of individual tubular elements 9 of the kit, each of said tubular elements being contained in and attached e.g. glued, at one end into a depression 10 in the sheet 7, which for convenience is held on openable rings 11, forming part of a ring binder 12.
  • a flap 13 also attached to the sheet 7 is arranged to swing with respect to the sheet 7, the flap 13 being formed with an integral projection 14 engageable with the depression 10 in the sheet 7 so that, when the flap 13 is pressed into engagement with the sheet 7, the projection 14 fits into and remains in engagement with the depression 10 by frictional grip.
  • the projection 14, being pressed out of the material of the flap 13, causes a depression 15 to be present on the other surface of the flap 13.
  • This depression contains information as indicated at 16 relating to the tubular element contained within the depression 10.
  • the test kit of Fig. 3 also contains a second group of tubular elements (not shown) connected to a second sheet 18 which in the illustration is mainly covered over by the upper group.
  • the test kit of Fig. 3 is intended for a purpose which requires three reagents to be applied in succession. The first and third of these reagents is each a common reagent contained in a single bottle and these bottles are contained in depressions in a sheet 19 of synthetic plastics material also attached to the rings 11 of the ring binder 12.
  • Projections 20 and 21 are formed by the bottle-containing depressions on the underface as illustrated in Fig. 3 of the sheet 19, each of these depressions containing a bottle containing the first and third reagents.
  • a label 22 giving information of the test for which the kit is to be used is attached to the 'inner surface of the ring binder 12 which in the illustration is mainly covered by the sheet 19.
  • kit of Fig. 3 is suitable for use as an immunoperoxidase staining test kit for the examination of samples of diseased tissue for diagnostic purposes.
  • a test kit as illustrated prepared for this purpose may contain in a bottle contained in the compartment formed by the projection 20 swine serum to be applied as the first layer (layer 1) on all tissue samples to be tested.
  • Each tubular element 9 is formed with segments each containing an aliquot of a particular reagent which may be selected to be applied as a second layer (layer 2) on a particular tissue sample.
  • reagents may be Rabbit anti-human IgD, Rabbit anti-human Kappa light chain, Rabbit anti-human Lambda light chain, Rabbit anti-human Muramidase ... and contained in a bottle occupying the compartment formed by the depression 17, Swine anti-Rabbit I gG horseradish peroxidase conjugated to be applied as the third layer (layer 3) on all tissue samples to be tested.
  • the test or rather the set of tests is performed by treating a tissue sample with the layer 1 reagent, then treating it with one of the layer 2 reagents contained in a selected tubular element 9 and then with the layer 3 reagent. Access to a selected tubular element 9 is obtained by pulling the appropriate flap 13 back thus exposing the element containing the desired reagent whereupon the element may be pulled out from the depression 10 containing it and the desired quantity of reagent expelled from the tubular element in one of the manners described.
  • Fig. 4 23, 24, and 25 denote three spools arranged in a block, the spools having a common axis of rotation 26.
  • tubular elements 27, 28 and 29, each tubular element being sealed .at each end (the free ends only being shown at 27A, 28A and 29A and at intermediate points 27B, 28B, 29B to give segments 30 each containing the same volume of reagent, the inner end of each tubular element (not shown) being attached to the spool around which it is wound, the block of spools 23, 24, 25 serving as a common anchorage for the tubular elements 27, 28, 29 respectively.
  • the block of spools is attached to a mounting 31 to which there is attached a panel or an adhesive label 32 carrying printed instructions identifying the test, the reagents being identified by colour-coding and/or bearing a printed identification corresponding to the instructions given at 32.
  • the tubular elements may be unrolled from the spools as and when required for use. If desired a cover (not shown) with three orifices may be fitted over the block of spools, the tubular elements passing out through the aforesaid orifices.
  • each continuous element has a plurality of segments constituted by reagent-containing compartments preformed or moulded from a flat strip or ribbon of inert synthetic plastics material.
  • the continuous element consists of a flat ribbon 33 of synthetic plastics material a in which/plurality of depressions defining a series of spaced compartments 34 of predetermined volume are preformed along the length of the ribbon.
  • Each compartment 34 is formed with a narrow neck portion 35.
  • a sealing layer 36 is bonded across the upper face of the ribbon 33 in order to close off the compartments 34 once they have been filled with a reagent.
  • Lines of weakening 37 e.g. a line of perforations, extend across the ribbon 33 and it will be noted that these lines of weakening extend across each free end of the narrow neck portion 35 of each compartment 34. Accordingly, a single compartment 34 can be severed from the end of the continuous element along a line of weakening 37. Such severance also fractures the neck portion 35 of the compartment 34 to allow the reagent contained therein to be dispensed as required.
  • Figs. 7 and 8 an arrangement is shown similar to that illustrated in Figs. 5 and 6 but wherein the continuous element is formed by a pair of continuous flat ribbons 38, 39 of synthetic plastics material each having preformed reagent-containing compartments 40 provided on one side thereof.
  • the two ribbons 38, 39 are passed in abutting relationship to a sealing and filling head (not shown) where they are sealed together along their length and as they are sealed together, the compartment 40 thus formed is: filled with a reagent.
  • lines of weakening 41 extend across the continuous element, each line of weakening intersecting a narrow neck portion 42 of each compartment 40.
  • a test is performed by choosing a particular length of the tubular elements containing the reagent to be applied first, tying a new knot in the tubular element (e.g. 2A in Fig. 1) or otherwise sealing the tubular element at an intermediate point in its length to isolate the quantity of reagent required, then cutting off the end of the tubular element below the knot or seal and expelling the reagent from the cut portion of element.
  • a new knot in the tubular element e.g. 2A in Fig. 1
  • the segment at the free end of the tubular element is separted by cutting across the pinched section forming a seal between that segment and the next segment, without perforating the seal of the next segment, opening the segment which has been detached and expelling the reagent from the detached portion of tubular element.
  • Figs. 5 to 8 Use of the embodiments illustrated in Figs. 5 to 8 is similar to that described above in relation to Figs. 3 and 4, except that when one segment is separated from its adjacent segment, the separated segment is opened by fracturing the segment along its line of weakness to break the neck of the reagent-containing compartment where the line of weakness extends thereacross.
  • one segment can be separated from an adjacent segment by cutting, or otherwise severing e.g. across a first line of weakness,, across the interconnecting strip or ribbon at a location between and spaced from the adjacent segments so that the neck of one segment is not broken by this operation.
  • the neck of a removed segment can be subsequently broken e.g. L by fracturing the segment along a separate line of weakness extending across the neck in order to enable expulsion of the reagent contained therein. (see Figs. 7 and 8).
  • a test kit of the invention is of small bulk since no bottles are required, or the number of bottles is substantially reduced, each kit is easily stored.
  • each kit on a ring may be suspended from a hook and each kit in which the common anchorage is a card or similar body, may be stacked or stored in a box and also there is no contamination of the reagent when removing a sample because the newly formed knot or seal in an unsegmented tubular element or the remaining portion of the seal between individual segments of a segmented tubular element completely isolates the reagent still remaining in the element after the quantity of reagent required has been removed.
  • the remainder of the kit may be incinerated, there being no bottles to dispose of and no pipettes or other measuring devices to be washed and dried and sterilized.
  • the tubular elements are easily filled by use of syringes or by suction.
  • the term 'reagent' as used in the present specification is used in a broad sense to include not only substances which react chemically or biologically with other substances in the test, e.g. with the test materials, but also other substances, e.g. buffer solutions, chromogenic substrates, counterstains and other reagents required for effecting the test, which must be added during the course of the test.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biomedical Technology (AREA)
  • Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Medicinal Chemistry (AREA)
  • Biotechnology (AREA)
  • Analytical Chemistry (AREA)
  • Microbiology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Investigating Or Analyzing Non-Biological Materials By The Use Of Chemical Means (AREA)
  • Devices For Use In Laboratory Experiments (AREA)
EP84303969A 1983-06-25 1984-06-12 Dispositif pour essais médicaux et chimiques Withdrawn EP0132285A3 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB838317313A GB8317313D0 (en) 1983-06-25 1983-06-25 Medical and chemical testing kit
GB8317313 1983-06-25

Publications (2)

Publication Number Publication Date
EP0132285A2 true EP0132285A2 (fr) 1985-01-30
EP0132285A3 EP0132285A3 (fr) 1987-10-28

Family

ID=10544801

Family Applications (1)

Application Number Title Priority Date Filing Date
EP84303969A Withdrawn EP0132285A3 (fr) 1983-06-25 1984-06-12 Dispositif pour essais médicaux et chimiques

Country Status (7)

Country Link
EP (1) EP0132285A3 (fr)
JP (1) JPS6036958A (fr)
AU (1) AU2985584A (fr)
DK (1) DK308484A (fr)
GB (1) GB8317313D0 (fr)
NZ (1) NZ208518A (fr)
ZA (1) ZA844564B (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998008093A1 (fr) * 1996-08-16 1998-02-26 Oy Medix Biochemica Ab Support solide de type fil flexible revetu pour immunodosages

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3189227A (en) * 1962-12-07 1965-06-15 American Home Prod Fluid dispenser
GB1073596A (en) * 1964-10-19 1967-06-28 Miles Lab Test device
US3469768A (en) * 1964-08-27 1969-09-30 Dow Chemical Co Dual compartment container
DE1598224A1 (de) * 1964-10-12 1970-07-30 Heinrich Dipl Chem Gerhard Her Verfahren und Roehrchen zur Durchfuehrung klinisch-chemischer Analysen
GB1214623A (en) * 1966-12-01 1970-12-02 Turtle Wax Mfg Ltd Improvements in and relating to flexible packages for fluent materials
GB1245999A (en) * 1969-01-30 1971-09-15 Royal Albert Elfast Jr An integrated testing device and package for reagent
EP0005538A1 (fr) * 1978-05-20 1979-11-28 Hoechst Aktiengesellschaft Emballage à alvéoles pour médicaments résistant aux tentatives d'ouverture par des enfants
WO1983001308A1 (fr) * 1981-10-05 1983-04-14 Mast Medical Ind Ltd Systeme de classification d'allergies et son procede de production et d'utilisation

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3189227A (en) * 1962-12-07 1965-06-15 American Home Prod Fluid dispenser
US3469768A (en) * 1964-08-27 1969-09-30 Dow Chemical Co Dual compartment container
DE1598224A1 (de) * 1964-10-12 1970-07-30 Heinrich Dipl Chem Gerhard Her Verfahren und Roehrchen zur Durchfuehrung klinisch-chemischer Analysen
GB1073596A (en) * 1964-10-19 1967-06-28 Miles Lab Test device
GB1214623A (en) * 1966-12-01 1970-12-02 Turtle Wax Mfg Ltd Improvements in and relating to flexible packages for fluent materials
GB1245999A (en) * 1969-01-30 1971-09-15 Royal Albert Elfast Jr An integrated testing device and package for reagent
EP0005538A1 (fr) * 1978-05-20 1979-11-28 Hoechst Aktiengesellschaft Emballage à alvéoles pour médicaments résistant aux tentatives d'ouverture par des enfants
WO1983001308A1 (fr) * 1981-10-05 1983-04-14 Mast Medical Ind Ltd Systeme de classification d'allergies et son procede de production et d'utilisation

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1998008093A1 (fr) * 1996-08-16 1998-02-26 Oy Medix Biochemica Ab Support solide de type fil flexible revetu pour immunodosages

Also Published As

Publication number Publication date
NZ208518A (en) 1987-09-30
DK308484D0 (da) 1984-06-22
JPS6036958A (ja) 1985-02-26
GB8317313D0 (en) 1983-07-27
AU2985584A (en) 1985-01-03
ZA844564B (en) 1987-04-29
EP0132285A3 (fr) 1987-10-28
DK308484A (da) 1984-12-26

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